Columbia Laboratories Announces Completion of CRINONE License Renewal

BOSTON, Sept. 8, 2014 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX) ("Columbia" or "the Company"), a provider of pharmaceutical development, clinical trial manufacturing, and advanced analytical and consulting services to the pharmaceutical industry, today announced that Merck Serono has completed a routine license renewal for CRINONE in one of its biggest markets. CRINONE is Columbia's largest revenue stream and shipments to this high-growth, high-volume market were temporarily suspended during the renewal period. Normalized shipments are expected to resume at the beginning of 2015. The new license will be in place for five years.  

"The completion of the CRINONE license renewal restores the predictability of this long-term revenue stream. Market data indicates that worldwide ex-US sales grew by 14.9% in the year to March 31^st and we expect to see a low double-digit rate of growth maintained as Merck Serono further expands its franchise and enters into new markets," said Frank Condella, Columbia's president and chief executive officer.

As previously disclosed, Merck Serono built up its inventory of CRINONE during the first three quarters of 2013 in anticipation of the routine license renewal in this one market. During the renewal period, which commenced in the fourth quarter of 2013, product could not be shipped without special agreement. Merck Serono placed an order as part of a one-time exception during the renewal process. The order was shipped in the third quarter of 2014 and will benefit that quarter's revenues.

About Columbia Laboratories

Columbia Laboratories, Inc. provides pharmaceutical development, clinical trial manufacturing, and advanced analytical and consulting services to the pharmaceutical industry.  The Company has a successful heritage in developing pharmaceutical products, particularly in women's health.  Its most successful product to date, CRINONE® 8% (progesterone gel), is marketed by Actavis, Inc. in the U.S. and by Merck Serono S.A. in over 60 additional countries worldwide.  For more information, please visit www.columbialabs.com.

CRINONE^® is a registered trademark of Actavis, Inc. in the U.S.

Forward Looking Statements

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," and similar expressions, which are generally not historical in nature. These include all statements relating to expected financial performance and future business or product developments.  Management believes that these forward-looking statements are reasonable as and when made.  However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.  For a discussion of certain risks and uncertainties associated with Columbia's forward-looking statements, please review Columbia's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2013.  

SOURCE Columbia Laboratories, Inc.

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